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KYPROLIS Drug Profile

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Which patents cover Kyprolis, and what generic alternatives are available?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-eight patent family members in thirty-six countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

Summary for KYPROLIS

International Patents:	188
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	46
Clinical Trials:	50
Patent Applications:	169
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYPROLIS
DailyMed Link:	KYPROLIS at DailyMed

Pharmacology for KYPROLIS

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Synonyms for KYPROLIS

(2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide

(2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide

(2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]amino]pentanamide

(Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide

(alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide

(S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide

(S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide

72X6E3J5AR

868540-17-4

AB0008111

AB01565867_02

AC-27051

AKOS025401910

AN-217

AOB87759

AS-17059

BC251806

BDBM50277889

BLMPQMFVWMYDKT-NZTKNTHTSA-N

C40H57N5O7

Carfilzomib

Carfilzomib (JAN/USAN/INN)

Carfilzomib (PR-171)

Carfilzomib [USAN:INN]

Carfilzomib?PR-171?/Kyprolis

Carfilzomib(PR171)

CAS-868540-17-4

CHEBI:65347

CHEMBL451887

CS-0984

CS-W004540

D00UVA

D08880

DB08889

DSSTox_CID_28616

DSSTox_GSID_48690

DSSTox_RID_82886

DTXSID4048690

FT-0696769

GTPL7420

HY-10455

J-501773

KB-75946

KS-00000SR1

Kyprolis (TN)

L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)-

MFCD11040997

MLS006011102

MolPort-027-950-907

N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide

NCGC00249613-01

NCGC00249613-02

NCGC00249613-03

ONO-7057

PR 171

PR-171

PX-171-007

QCR-96

RL05381

S-7798

s2853

SC-91032

SCHEMBL85165

SMR004660024

SR-01000941582

SR-01000941582-1

Tox21_113079

Tox21_113079_1

UNII-72X6E3J5AR

Y0441

ZINC49841054

US Patents and Regulatory Information for KYPROLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012		RX	Yes	Yes
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012		RX	Yes	Yes
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012		RX	Yes	Yes			Y	Y

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Paragraph IV (Patent) Challenges for KYPROLIS

Drugname	Dosage	Strength	RLD	Submissiondate
	For Injection	30 mg/vial		2017-10-05
	For Injection	60 mg/vial		2016-07-20

Non-Orange Book US Patents for KYPROLIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,324,174	Compounds for enzyme inhibition
8,198,270	Compounds for proteasome enzyme inhibition
8,207,124	Compounds for enzyme inhibition
8,088,741	Compounds for enzyme inhibition

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International Patents for KYPROLIS

Country	Document Number	Estimated Expiration
Canada	2562411
Ecuador	SP11011027
Australia	2005271232
Portugal	2030981

Supplementary Protection Certificates for KYPROLIS

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0017	France		PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
0805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123